Unidox Solutab

Leaflet accompanying the packaging: patient information

Unidox Solutab, 100 mg, tablets for oral suspension

Doxycycline

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Unidox Solutab and what is it used for
• 2. Important information before taking Unidox Solutab
• 3. How to take Unidox Solutab
• 4. Possible side effects
• 5. How to store Unidox Solutab
• 6. Contents of the pack and other information

1. What is Unidox Solutab and what is it used for

The active substance of Unidox Solutab, doxycycline, is an antibiotic belonging to the group of tetracyclines, used to treat infections caused by microorganisms sensitive to doxycycline.
Unidox Solutab is used to treat infections of the following organs and tissues:

• mild, non-hospital pneumonia, including infections caused by the following atypical pathogens: Chlamydophila(formerly Chlamydia) pneumoniae; Mycoplasma pneumoniaeand Chlamydophila(formerly Chlamydia) psittaci;
• exacerbation of chronic bronchitis;
• urinary tract infections (sexually transmitted diseases) - infections caused by Chlamydia trachomatis, including uncomplicated urethral, cervical, and rectal infections; non-gonococcal urethritis caused by Ureaplasma urealyticum; doxycycline is also indicated for the treatment of soft chancre, lymphogranuloma venereum, and granuloma inguinale, as well as one of the possible drugs for the treatment of gonorrhea and syphilis;
• skin infections - common acne, if there is a need to use an antibiotic;
• gastrointestinal tract infections - Entamoebaspp. infections as adjunctive treatment, cholera (Vibrio cholerae);
• Lyme disease;
• eye infections - conjunctivitis caused by Chlamydia trachomatis;
• Q fever caused by Coxiella burnetti;
• ricketsiosis;
• other infections - recurrent fever (Borrelia recurrentis), plague (Yersinia pestis), tularemia (Francisella tularensis), brucellosis (Brucellaspp.), anthrax (Bacillus anthracis), ornithosis (Chlamydia psittaci);
• leptospirosis;
• pasteurellosis;
• malaria caused by Plasmodium falciparumresistant to chloroquine;
• malaria prophylaxis. Tetracycline should not be used in Salmonellaspp. infections.

Official guidelines on the proper use of antibacterial agents should be taken into account.

2. Important information before taking Unidox Solutab

When not to take Unidox Solutab:

• during the second and third trimester of pregnancy (see also "Pregnancy, breastfeeding and fertility") Do not take Unidox Solutab during tooth development (pregnancy, infancy, and childhood under 8 years) as it may cause permanent tooth discoloration (yellow-gray-brown) or affect tooth development. The effect of doxycycline on tooth discoloration and delayed bone growth in newborns and infants breastfed by women taking it cannot be ruled out (see also "Pregnancy, breastfeeding and fertility"). There may be circumstances (e.g., severe or life-threatening condition) in which the doctor prescribes Unidox Solutab to a child under 8 years of age, considering that the expected benefits outweigh the risk of taking the medicine.

Warnings and precautions

Before starting Unidox Solutab, discuss with your doctor:

• severe skin reaction (see section 4). Discontinue treatment and consult a doctor.
• after exposure to sunlight or solarium, the first symptoms of sunburn appear. Discontinue treatment and consult a doctor. If you experience any of the following during treatment:
• persistent diarrhea with fever (see section 4). Consult a doctor, as it may be a sign of pseudomembranous or staphylococcal colitis (complications that sometimes occur with antibiotic use). The doctor may decide to discontinue the medicine and prescribe appropriate treatment. To rehydrate, drink plenty of fluids made from special preparations available at pharmacies. Do not take anti-diarrheal medications.
• you experience: headache, blurred vision, double vision, nausea, vomiting, ringing in the ears, dizziness, pain behind the eyeballs, flashes of light in the eyes. Consult a doctor, as these may be symptoms of benign intracranial hypertension observed with doxycycline use.
• you experience a secondary infection (infection with microorganisms resistant to doxycycline, including fungal infections). The doctor may recommend discontinuing the medicine and starting appropriate treatment.

Taking the medicine without lying down or with too little water may cause esophageal inflammation or ulceration.
If you are taking Unidox Solutab for a long time, your doctor may recommend periodic laboratory tests (e.g., blood morphology or liver and kidney function tests).

Unidox Solutab and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Unidox Solutab may interact with the following medicines:

• antacids (medicines used to reduce stomach acid). Avoid taking preparations containing aluminum, calcium, or magnesium and products containing iron or bismuth salts at the same time.
• activated charcoal, ion exchange resins (e.g., cholestyramine) may reduce doxycycline absorption. These medicinal products should be taken 2-3 hours after taking Unidox Solutab;
• substances that increase stomach pH (including products containing calcium) affect tetracycline absorption (including Unidox Solutab). Do not take these products with Unidox Solutab.
• Quinapril (a medicine used for hypertension and heart failure) may reduce doxycycline absorption.
• anticoagulants - taking Unidox Solutab with anticoagulants increases their effect; the doctor may adjust the dose of the anticoagulant.
• other antibiotics with bactericidal action (including beta-lactam antibiotics) - taking these antibiotics with Unidox Solutab may reduce their effect. Do not take them at the same time.
• substances that induce liver enzymes (e.g., barbiturates and their derivatives, rifampicin, carbamazepine, phenytoin, primidone, phenobarbital, alcohol) - taking these substances with Unidox Solutab may reduce the effect of Unidox Solutab.
• Methoxyflurane (an anesthetic) - taking methoxyflurane with Unidox Solutab may cause kidney damage.
• concomitant administration of cyclosporine with Unidox Solutab should be carried out under close medical supervision, as cyclosporine levels in the blood may increase.
• sulfonylurea derivatives (used in diabetes) - Unidox Solutab may enhance their effect. The doctor may adjust the dose of the glucose-lowering medicine.
• retinoids (vitamin A derivatives). There is a risk of transient increased intracranial pressure if doxycycline is used shortly before, during, or after retinoid treatment. Avoid taking these medicines at the same time.
• glucose urine test results - test results performed during Unidox Solutab treatment may be unreliable. The medicine may cause false laboratory test results in the form of increased catecholamine levels in the urine. If laboratory tests are planned, inform your doctor that you are taking Unidox Solutab.

Unidox Solutab with food and drink

It is recommended to take the suspension (after uniform mixing of the tablet with water) during meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Tetracyclines may cause tooth and bone development disorders in the fetus, so Unidox Solutab should not be taken during the second and third trimesters of pregnancy. As a precautionary measure, it is recommended to avoid taking Unidox Solutab during the first trimester of pregnancy.
Doxycycline should not be taken during breastfeeding. Tetracyclines pass into human milk and their effect on tooth discoloration and delayed bone growth in newborns and infants breastfed by women taking them cannot be ruled out. A decision should be made to either discontinue breastfeeding or discontinue Unidox Solutab, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.
In animal studies, oral administration of doxycycline had an adverse effect on fertility and reproductive performance. There are no data on the effect of doxycycline on human fertility.

Driving and using machines

Unidox Solutab has a moderate effect on the ability to drive and use machines. Since Unidox Solutab may cause dizziness, blurred or double vision, before driving or operating machinery, the patient should make sure how they react to the medicine. If these symptoms occur, do not drive or operate machinery.

Unidox Solutab contains approximately 64.1 mg of lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Unidox Solutab

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Children from 8 to less than 12 years old
In children from 8 to less than 12 years old, doxycycline should be used when other medicines are not available, likely to be ineffective, or contraindicated.
In such cases, the following doses are used:
For children with a body weight of 45 kg or less: 4.4 mg/kg body weight on the first day (as a single dose or in 2 divided doses), and then from the second day onwards, 2.2 mg/kg body weight (as a single dose or in 2 divided doses). For the treatment of more severe infections, a dose of up to 4.4 mg/kg body weight should be given throughout the treatment period.
For children with a body weight over 45 kg, the dose is the same as for adults: see below.
The duration of treatment depends on the type of infection.
When using Unidox Solutab, a dose less than 100 mg cannot be achieved. The doctor will decide which other available doxycycline product to use.
Adults and children from 12 to less than 18 years old
On the first day, 200 mg (as a single dose or in divided doses), then 100 mg per day. For the treatment of more severe infections, a dose of 200 mg should be given throughout the treatment period. The duration of treatment depends on the type of infection.
Duration of treatment
Treatment usually lasts from 5 to 10 days. The medicine should be given for at least 1-2 days after the symptoms have resolved. In some infections, the doctor may decide to extend the treatment period to more than 10 days.
Dosing in specific infections
Urinary tract infections: in uncomplicated urethral, cervical, and rectal infections in adults caused by Chlamydia trachomatisand non-gonococcal urethritis caused by Ureaplasma urealyticum, 100 mg is given twice a day for 7 days.
Alternative treatment for acute epididymitis and prostatitis caused by Chlamydia trachomatisor Neisseria gonorrhoeae: 100 mg twice a day for 10 days.
Primary and secondary syphilis: 200 mg twice a day for 2 weeks.
Lymphogranuloma venereum: 200 mg for 21 days.
Lyme disease: 200 mg per day for 14 to 21 days (in early stages of the disease) to 1 month (in later stages of the disease).
Anthrax: prophylaxis after exposure - 100 mg twice a day for 60 days, cutaneous form - 100 mg twice a day for 60 days, inhalational and gastrointestinal forms - initially 100 mg twice a day as part of combination therapy; the total treatment duration is 60 days.
Common acne: usually 50 mg of doxycycline per day for up to 12 weeks.
Method of administration

• The tablet should be mixed with a small amount of water (at least 50 ml) and stirred well to obtain a uniform suspension. The suspension should be taken immediately after preparation.
• Do not swallow the tablet before mixing it with water
• The suspension should be taken while standing or sitting
• The medicinal product should be taken long before bedtime (do not take it just before bedtime). It is essential not to lie down for at least 30 minutes after taking the mixture, so it can move to the stomach as quickly as possible, preventing throat or esophageal irritation.
• The suspension is best taken during meals

The dividing line on the tablet is not intended for dividing the tablet into equal doses and is placed on the tablet for aesthetic reasons.

Taking a higher dose of Unidox Solutab than recommended

Contact your doctor immediately.
It may cause liver damage, the symptoms of which are vomiting, fever, jaundice, bruising, and dark stools, as well as changes in some liver, kidney, and blood coagulation parameters.
Overdose may cause esophageal irritation and ulceration, accompanied by chest pain, difficulty swallowing, and esophagitis. This can be prevented by drinking the tablet with a large amount of water (about 200 ml; children: about 125 ml). It is not recommended to induce vomiting to prevent esophageal irritation.
Overdose is treated symptomatically. The doctor will monitor electrolyte balance and may recommend activated charcoal and/or a laxative. Hemodialysis does not affect the removal of doxycycline from the body.

Missing a dose of Unidox Solutab

If you miss a dose at the scheduled time, take it as soon as possible, unless it is time for the next dose. In this case, do not take the missed dose and continue treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Unidox Solutab can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

Rare (affect 1 to 10 people per 10,000)

• drug reaction with eosinophilia and systemic symptoms (DRESS, drug reaction with eosinophilia and systemic syndromes)
• inflammation of the small and large intestine (including pseudomembranous colitis) manifested as stomach upset, loss of appetite, severe and persistent or bloody diarrhea
• toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome - a severe skin reaction in the form of blistering on large areas of skin, mouth, eyes, and genitals Very rare (affect less than 1 person per 10,000)
• hypersensitivity reaction (including anaphylactic shock, anaphylaxis, anaphylactoid reaction, anaphylactoid purpura, hypotension, pericarditis, angioedema, exacerbation of systemic lupus erythematosus, dyspnea, serum sickness, peripheral edema, tachycardia, and urticaria), which may manifest as sudden onset of wheezing, difficulty breathing, chest pain, fever, swelling of the eyelids, face, or lips, rash, or itching (especially on large areas of the body)
• irritation of the meninges with swelling of the optic disc (which may be associated with headache, blurred vision, double vision, nausea, vomiting, ringing in the ears, dizziness, pain behind the eyeballs, and flashes of light in the eyes)
• pseudomembranous colitis manifested as abdominal pain and diarrhea with fever

If you experience any of the following side effects, contact your doctor immediately:

Uncommon (affect 1 to 10 people per 1,000)

• photosensitivity, which may manifest as skin rash, itching, redness, or severe sunburn - in this case, discontinue treatment and contact your doctor immediately Rare (affect 1 to 10 people per 10,000)
• hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia. If your blood tests are not within normal limits, contact your doctor.
• joint pain, muscle pain Frequency not known (cannot be estimated from available data)
• Jarisch-Herxheimer reaction, causing fever, chills, headache, muscle pain, and skin rash, which is usually self-limiting. It occurs soon after starting doxycycline treatment for spirochetal infections, such as Lyme disease.
• esophagitis, esophageal ulceration, which manifests as difficulty swallowing, throat inflammation, and heartburn
• tachycardia (rapid heart rate)

Other side effects.

Common (affect 1 to 10 people per 100)

• vaginitis, fungal infections
• nausea, anal itching, black hairy tongue, oral inflammation, genital area inflammation
• bone development disorders
• tooth development disorders
• skin irritation

Uncommon (affect 1 to 10 people per 1,000)

• headache
• vomiting, diarrhea, tongue inflammation
• maculopapular rash

Rare (affect 1 to 10 people per 10,000)

• brown-black discoloration of the thyroid
• anorexia
• tinnitus
• pericarditis
• urticaria
• abdominal pain, difficulty swallowing, indigestion, pancreatitis, inhibition of vitamin B-producing bacteria
• liver function disorders, hepatotoxicity with transient increased liver enzyme activity, hepatitis, jaundice, liver failure
• urticaria, exfoliative dermatitis
• increased blood urea levels
• skin discoloration (darker spots on the skin)*

Very rare (affect less than 1 person per 10,000)

• bulging fontanelle

Frequency not known (cannot be estimated from available data)

• prolonged prothrombin time
• porphyria
• photoonycholysis (separation of the nail from the nail bed, which sometimes leads to complete nail detachment after sun exposure)
• hypoplasia of tooth enamel, tooth discoloration (see also "When not to take Unidox Solutab" in section 2)
• fixed drug eruptions

*with long-term use of doxycycline

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Unidox Solutab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP:". The expiry date refers to the last day of that month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Unidox Solutab contains

• The active substance of Unidox Solutab is doxycycline. Each tablet for oral suspension contains 100 mg of doxycycline in the form of doxycycline monohydrate.
• The other ingredients are: microcrystalline cellulose, saccharin (E 954), hydroxypropylcellulose (E 463), hypromellose (E 464), colloidal silicon dioxide (E 551), magnesium stearate (E 572), lactose.

What Unidox Solutab looks like and contents of the pack

Yellow (light yellow or gray-yellow to brown with spots), round, biconvex tablets for oral suspension with the marking "173" on one side and a dividing line on the other side. The dividing line on the tablet is not intended for dividing the tablet into equal doses and is placed on the tablet for aesthetic reasons.
A carton contains one blister pack of 10 tablets.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden, Netherlands

Date of last revision of the leaflet: June 2024